Principal / Senior Mechanical Engineer

engineeringjobs.net, Inc.; Franklin (TN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Life & AD&D

Disability coverage

401(k) match

HSA/FSA

Job summary

engineeringjobs.net, Inc. is seeking a Principal/Senior Mechanical Engineer to lead design, development, and optimization of complex medical devices and combination products from concept through launch.

The role requires deep medical device expertise, strong product development and risk management skills, and the ability to mentor other engineers while delivering on schedule and budget in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical Engineering required; master's preferred.
• 8 years of dedicated mechanical design experience with at least 5 years in medical devices.
• Expert-level proficiency in CAD and solid modeling (SolidWorks or equivalent).
• Deep knowledge of medical device design controls and standards (ISO 13485, ISO 14971, ISO 60601).
• Ability to work independently, analyze data rigorously, and manage multiple priorities.

Responsibilities

• Lead mechanical architecture and detailed design of complex medical devices using CAD and simulation tools.
• Translate user needs into functional requirements and prototypes using advanced manufacturing techniques.
• Perform tolerance analysis, GD&T, FEA/CFD, and kinematic modeling for reliability in clinical environments.
• Develop and execute Verification and Validation protocols within ISO 13485 and FDA 21 CFR Part 820.
• Partner with manufacturing, quality, and supply chain to optimize design for manufacturability, assembly, and cost.
• Drive risk management per ISO 14971 including hazard analysis, FMEA, and root-cause investigations.
• Provide technical guidance and mentorship to junior engineers and design staff.
• Manage multiple projects balancing priorities, timelines, and budgets.
• Prepare technical documentation and presentations for stakeholders.

Skills

Independent worker

Data analysis

Prioritization

Technical communication

Mentorship

Education

Bachelor's degree in Mechanical Engineering

Master's degree preferred

Tools

SolidWorks

Job description

Who Our Client Is

Our client is a medical device organization focused on developing solutions that support patient care. Their team brings together engineering, quality, manufacturing, and other disciplines to advance complex medical technologies.

What Our Client Needs

Our client is seeking a Principal / Senior Mechanical Engineer to lead the design, development, and optimization of complex medical devices, materials, and combination products from concept through launch.

Who You Are

You are an experienced mechanical engineer with deep medical device expertise and a strong command of product development, design controls, and risk management. You work independently, analyze data rigorously, manage competing priorities, and communicate technical information clearly. You are also comfortable providing technical guidance and mentorship to other engineers.

What You'll Do

• Lead the mechanical architecture and detailed design of complex, multi-component, patient-connected medical devices using CAD and simulation tools.
• Translate user needs into functional requirements, designs, and prototypes using advanced manufacturing techniques.
• Perform tolerance analysis, including GD&T, structural and thermal FEA, and kinematic modeling to support reliability in clinical environments.
• Develop and execute Verification and Validation protocols within ISO 13485 and FDA 21 CFR Part 820 quality systems.
• Partner with manufacturing, quality, and supply chain teams to optimize designs for manufacturability, assembly, and cost at scale.
• Drive technical risk management in accordance with ISO 14971 through hazard analysis, fault tree analysis, FMEA, and root cause investigations.
• Provide technical guidance and mentorship to junior engineers and design staff.
• Manage multiple projects while balancing technical priorities, timelines, and budgets.
• Prepare technical documentation, reports, and presentations for internal and external stakeholders.

This role includes technical mentorship responsibilities. Travel requirements were not specified.

What You'll Need

• Bachelor's degree in Mechanical Engineering; master's degree preferred.
• 8 years of dedicated mechanical design experience, including at least 5 years in the medical device industry.
• Expert-level proficiency in CAD and solid modeling tools such as SolidWorks or equivalent.
• Strong knowledge of materials, fabrication, manufacturing, and injection molding technologies.
• Experience with FEA, CFD, or other engineering simulation tools.
• Deep knowledge of medical device design controls and applicable standards, including ISO 13485, ISO 14971, and ISO 60601.
• Ability to work independently, rigorously analyze data, and manage multiple priorities.
• Excellent written and verbal communication skills.

What They Offer

• Your well-being matters. The benefits package is designed to support your health, financial future, and life outside of work.
• Comprehensive health coverage: Medical, dental, and vision insurance
• Protection for you and your family: Life and AD&D insurance
• Income protection: Short- and long-term disability coverage
• Plan for your future: 401(k) with a generous company match
• Flexible health care savings: HSA and FSA options with company contributions
• Support your well-being: Access to a comprehensive wellness program
• Resources when you need them: Employee Assistance Program (EAP)
• Time to recharge: Generous paid time off (PTO)

The benefits are designed to provide meaningful support across the different stages of your career and life, helping you take care of what matters today while planning for the future.

Equal Opportunity Statement

Our client believes that diversity fuels innovation, strengthens teams, and drives success. They are committed to fostering a workplace where every individual---regardless of background---feels valued, respected, and empowered to thrive. Discrimination or harassment of any kind is strictly prohibited.

Our client does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by applicable laws. Their commitment extends beyond compliance; they actively cultivate an inclusive culture where diverse perspectives are welcomed, and every employee has an equal opportunity to contribute and succeed.